MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 4.0MM HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Catalog Number 314.05

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reportedly there was no patient involvement.Date of event is unknown.Device is an instrument and is not implanted/explanted.Therapy date of concomitant device is unknown.A device history record review was requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that after an orthopedic procedure on (b)(6) 2018, a cannulated hexagonal screwdriver was found to be defective.It won't slide over the guide wire.The issue was identified in the sterile processing department.There was no procedure and patient involvement.Concomitant device reported: unknown guidewire (part # unknown, lot # unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record review was performed for the subject device: part number: 314.05 , synthes lot number: 4996202 , supplier lot number: n/a , release to warehouse date: 02-may-2005 , expiration date: n/a.Manufactured by synthes brandywine , no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product development investigation was performed for the subject device: investigation flow: device interaction / functional visual inspection: visual inspection performed at customer quality (cq) confirmed the condition of damaged distal cannualted hex tip, which agrees with the reported complaint condition.Visual examination under 10x magnification revealed that the cannulated hex walls have collapsed internally at the distal edge (post manufacturing damage on the returned 13+ year old reusable instrument).Functional test: a functional test to replicate the reported complaint condition could not be performed at cq as the guide wire was not returned.However, a dimensional inspection using best fit gauge pins was performed and documented in below dimensional inspection.Document/specification review: the returned device was manufactured in may 2005 and is over 13 years old.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Relevant drawings for the returned instrument were reviewed (both from the time of manufacture and current revision): top-level (314_05), shaft component (314_05_1).The 4.0mm cannulated hexagonal screwdriver (part#314.05) is a reusable trauma instrument noted in approximately 15 system technique guides including: 4.5mm va-lcp curved condylar plate and 6.5mm/7.3mm cannulated screw.In the cannulated screw system the returned driver is one of four instruments intended for screw insertion (the others being 313.93, 314.04 and 314.23).No product design issues or discrepancies were observed.Dimensional inspection: the inside diameter/cannulation of the returned device at distal tip measured ø2.86mm at cq (gp29) which is undersized with respect to the specification of ø2.9mm +0.1/-0.0mm per shaft component drawing 314_05_1 revision d.Visual examination under 10x magnification revealed that the cannulated hex walls have collapsed internally at the distal edge (post manufacturing damage on the returned 13+ year old reusable instrument).The inside diameter/cannulation of the returned device's shaft at proximal end measured ø3.44mm at cq (gp29) which is within specification of ø3.2mm +0.3/-0.0mm per shaft component drawing 314_05_1.Conclusion: a definitive root cause for the damaged tip could not be determined based on the provided information.The most likely cause is cumulative wear and rough handling for the returned 13+year old reusable cannulated instrument.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CANNULATED 4.0MM HEXAGONAL SCREWDRIVER
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7649795
• MDR Text Key: 112862370
• Report Number: 2939274-2018-52677
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188410
• UDI-Public: (01)10886982188410
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.05
• Device Lot Number: 4996202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1